Senior Compliance Specialist

About Us

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

Here at RoslinCT, our team contributes to the development of revolutionary treatments. We live by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We prioritize our employees by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are key to our success, and we focus on developing our corporate culture, personal growth, and the ability to impact patients.

Responsibilities

• Serve as the Operations compliance subject matter expert, supporting GMP manufacturing and operational activities across the site.
• Drive timely and effective execution of quality system activities to ensure compliance with regulatory requirements, company procedures, and client expectations.
• Partner with Operations leadership to identify compliance risks and implement sustainable solutions that improve quality, efficiency, and inspection readiness.
• Build strong cross-functional relationships with Manufacturing, MS&T, Quality Assurance, Validation, Engineering, Supply Chain, and other Operations functions to support compliant execution.
• Utilize quality metrics and trend analysis to identify opportunities for continuous improvement and operational excellence.
• Lead complex deviations, investigations, CAPAs, Change Controls, and Effectiveness Checks for Operations.
• Conduct thorough root cause investigations utilizing risk-based problem-solving methodologies including Ishikawa, 5 Whys, 6Ms.
• Ensure investigations are scientifically sound, technically accurate, and completed within established timelines.
• Partner with appropriate SMEs to assess impact to product quality, compliance, and patient safety associated with quality events.
• Support establishment of the appropriate KPIs for the operational team and ensure they are met.
• Partner with Quality Assurance to ensure consistent execution of GMP quality systems across Operations.
• Collaborate with Manufacturing, MS&T, Validation, Engineering, and Supply Chain to resolve quality issues and implement effective corrective actions.
• Maintain inspection readiness by ensuring quality system records are complete, accurate, and audit ready.
• Support internal audits, client audits, and regulatory inspections as the Operations subject matter expert.
• Manage implementation of Operations CAPA/commitments from audit/inspection responses.
• Prepare investigation summaries, responses, and supporting documentation for audits and regulatory inspections.
• Provide guidance on GMP requirements, quality risk management, and quality system expectations to Operations personnel.
• Identify opportunities to improve quality system effectiveness, investigation quality, and compliance processes.
• Support Quality Systems with deploying improvements to the eQMS as an operational SME by providing input, training materials, and SOP updates.
• Analyze deviation and investigation trends to drive systemic improvements under CAPA or OE initiatives.
• Support implementation of Lean and Quality Risk Management principles within Operations.
• Participate in cross-functional initiatives focused on operational excellence, compliance, and process optimization.
• Recommend and implement improvements that reduce recurring quality events and strengthen quality culture.
• Provide technical mentorship and coaching on investigation practices, root cause analysis, and GMP compliance.
• Influence quality and operational decisions through scientific, risk-based, and data-driven recommendations.
• Serve as a Qualified Trainer for deviation and investigation writing.
• Foster a proactive culture of compliance, continuous improvement, and operational excellence.
• Demonstrate sound judgment, accountability, and professionalism while managing multiple complex priorities in a dynamic GMP environment.

Requirements

• Strong technical expertise in GMP quality systems and cell therapy manufacturing operations.
• Demonstrated ability to lead complex investigations using structured root cause analysis and risk-based decision making.
• Excellent analytical and critical thinking skills with the ability to interpret technical and manufacturing data to identify trends and systemic issues.
• Strong technical writing skills with experience authoring deviations, investigations, CAPAs, change controls, and SOPs.
• Ability to perform and lead risk assessments using FMEA/FASEP methodologies is a plus.
• Exceptional organizational skills with the ability to prioritize and manage multiple complex activities in a fast-paced GMP environment.
• Excellent interpersonal, verbal, and written communication skills with the ability to collaborate effectively across Operations and Quality organizations.
• Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint) and electronic Quality Management Systems (eQMS).

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Biotechnology, Biomedical Engineering, Microbiology, or a related scientific discipline with 8+ years of relevant industry experience, or a Master's degree with 5+ years of relevant industry experience.
• Minimum 5 years of experience leading quality system activities, including deviations, investigations, CAPAs, and change controls in a regulated GMP environment.
• Demonstrated experience leading complex technical investigations involving manufacturing processes, equipment, facilities, materials, or documentation.
• Experience partnering cross-functionally with Manufacturing, MS&T, Quality Assurance, Validation, Engineering, and Supply Chain.
• Experience supporting regulatory inspections, client audits, and inspection readiness activities is preferred.
• Lean Six Sigma, Quality Risk Management, or formal root cause analysis training is desirable.